SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
NCT00337194 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2015-02-23
Summary
This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has returned after a period of improvement or did not respond to previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination chemotherapy may kill more cancer cells and shrink tumors.
Conditions
- Adult Lymphocyte Depletion Hodgkin Lymphoma
- Adult Lymphocyte Predominant Hodgkin Lymphoma
- Adult Mixed Cellularity Hodgkin Lymphoma
- Adult Nodular Sclerosis Hodgkin Lymphoma
- Recurrent Adult Hodgkin Lymphoma
Interventions
- BIOLOGICAL
-
monoclonal antibody SGN-30
Given IV
- OTHER
-
placebo
Given IV
- DRUG
-
vinorelbine tartrate
Given IV
- DRUG
-
pegylated liposomal doxorubicin hydrochloride
Given IV
- DRUG
-
gemcitabine hydrochloride
Given IV
- OTHER
-
laboratory biomarker analysis
Correlative studies
- OTHER
-
pharmacological study
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Kristie Blum · Cancer and Leukemia Group B
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
- Primary Completion
- 2008-09-30
- Completion
- 2014-10-31
Countries
- United States
Study Locations
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